Internal Support Regulatory Writing

Criterion Edge can support your internal document writing requirements

Our team of regulatory writers and QC reviewers understand the workflow pressures within organizations, which are often the result of multiple or urgent requests for updates, amendments, new documentation practices or a lack of resources.

Let us help. Put our writers and support team to work on your internal writing needs. Listed here are just a few examples of the deliverables we can provide. Of course, please contact us for more information. We’d love to hear about the requirements of your particular project!

Key Internal Support Deliverables include:

  • Protocols and Clinical Investigation Plans SOPs
  • Informed Consent Forms
  • Clinical Narratives
  • Evidence Gap Assessments
  • Briefing Documents
  • Working Group/KOL Advisory Board Summaries
  • Response Documents